Remimazolam for Colonoscopy in IBD Patients

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

September 7, 2025

Study Completion Date

September 30, 2025

Conditions
IBD (Inflammatory Bowel Disease)
Interventions
DRUG

Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation.

\- Remimazolam + Fentanyl IV fentanyl 100 mcg is given first, followed after 1 minute by IV remimazolam 5 mg over 1 minute. Additional 2.5 mg boluses may be given every 2 minutes as needed. Colonoscopy starts 1 minute after sedation. Vital signs are monitored throughout.

DRUG

Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation.

\- Midazolam + Fentanyl (≤1000 caratteri) IV fentanyl 100 mcg is given first, followed after 1 minute by IV midazolam 3 mg over 1 minute. Additional midazolam may be administered based on clinical judgment. Colonoscopy starts 1 minute after sedation. Vital signs are monitored throughout.

Trial Locations (1)

20089

Humanitas Research Hospital, Rozzano

All Listed Sponsors
lead

Humanitas Clinical and Research Center

OTHER